Phlexy-10 System

An interchangeable system of phenylalanine-free medical foods for the dietary management of phenylketonuria in individuals over the age of 1 year including pregnant women and women of child-bearing age.

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This formulation is available in the US and Canada.

Directions for Preparation and Use:

The Phlexy-10 products must be consumed in conjunction with natural protein, fluid and other nutrients in quantities prescribed by a physician or dietitian to meet phenylalanine and general nutrition requirements. Fat, carbohydrate and low protein sources may be used to supply needed calories and to fulfill essential fatty acid requirements.

Intake of the Phlexy-10 products will vary depending on the age, body weight and medical condition of the individual. Intake is adjusted to maintain normal growth and development. One packet of the drink mix, one bar, 20 capsules or 10 tablets provide 10 g of amino acids, equivalent to 8.33 g of protein.

The Phlexy-10 products do not contain vitamins, minerals, or trace elements. It is essential that these nutrients are supplied separately. Phlexy-Vits are available to be used as a supplement to the Phlexy-10 System. One 7 g packet supplies the majority of vitamins and minerals needed to meet the RDA of individuals 11 years and older.

Mixing Instructions:

• Phlexy-10 Drink Mix
  Mix the contents of one packet with a small amount of water, stirring into a thick paste. Continue stirring while adding water to make up a final volume of approximately 100 mL (~3.5 fl oz.).
• Phlexy-10 Bar, Phlexy-10 Capsules and Phlexy-10 Tablets
  These products should be taken with water or a non-phenylalanine containing beverage.

Precaution:

• Must only be given under strict medical supervision to patients with proven phenylketonuria. Not intended for use as the sole source of nutrition. Not intended for infants under 1 year of age. Not for parenteral use.

Storage:

• Phlexy-10 Drink Mix, Phlexy-10 Capsules, and Phlexy-10 Tablets should be stored in a cool, dry place. Once reconstituted, Phlexy-10 Drink Mix should be stored in a refrigerator and must be used within 24 hours of preparation. Once Phlexy-10 Capsules or Phlexy-10 Tablets are opened, reseal can and store in a cool, dry place (not in refrigerator) and use within one month. Phlexy-10 Bars should be stored in a refrigerator. Allow to return to room temperature before consuming.

Ordering Information:

Clinical References

• Moseley K et al. Sapropterin Dihydrochloride (6R-BH4) and Maternal Phenylketonuria. ICAN Infant, Child and Adolescent Nutrition 2009; vol 1, no 5:262-6.
• MacDonald A et al. Protein substitutes for PKU: What’s new? J Inherit Metab Dis. 2004; 27:363-371.
• Rohr F et al. Acceptability of a new modular protein substitute for the dietary treatment of phenylketonuria. J Inherit Metab Dis. 2001; 24:623-630.
• Moseley K, Koch R. A new multi-module medical food product improves compliance in the treatment of phenylketonuria. Poster presented at annual meeting of SSIEM (Society for the Study of Inborn Errors of Metabolism), Cambridge, England, 2000.